Robotically augmented catheter manipulation handle

ABSTRACT

Apparatus and associated methods relate to a catheter manipulation handle with user interface controls for steering a catheter in situ while providing an augmented (e.g., motorized, powered and tunable precision steering, and perforation safeguards) control and feedback user experience. In an illustrative example, the catheter manipulation handle may provide motor assisted operation to automatically rotate and/or deflect a distal tip of the catheter to steer and guide the distal tip to a target location in the patient&#39;s vasculature system. The augmented feedback may include, for example, haptic feedback via the handle. Haptic, audible, and/or visual feedback via the handle may indicate, for example, proximity or engagement of the distal tip with sensitive tissue. In some examples, the handle&#39;s augmented operation may advantageously amplify feedback signals to enhance the user&#39;s perception of the patient&#39;s safety with respect to the safe passage of the distal tip through the patient&#39;s vasculature.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 62/292,699 titled “Robotically Assisted Steerable Catheter,” filedby Ryan Douglas, et al. on Feb. 8, 2016.

This application incorporates the entire contents of the foregoingapplication(s) herein by reference.

TECHNICAL FIELD

Various embodiments relate generally to catheter control mechanisms thataugment catheter steering directly controlled by a medical professional.

BACKGROUND

Medical teams have available a wide variety of catheters, to enableprovision of the right products for their patients' unique medicalneeds. For decades, with the help of catheters, medical teams have beenable to drain fluids from body cavities, administer medicationsintravenously, perform surgical procedures and administer anesthetics,for example. As technology progressed, medical instrument designersprovided modern medicine teams with guiding catheters and sheaths.Guiding catheters and sheaths are frequently used in many medicalprocedures due to their minimally invasive nature. For example, patientsundergoing cardiac or other vascular procedures with guiding cathetersand sheaths receive a minimally-sized surgically-placed lumen (opening)to the skin.

Guiding catheters and sheaths, otherwise named “steerable” catheters andsheaths, employ control wires that pass from the catheter interfacethrough the catheter shaft and terminate at the catheter shaft tip.Tension applied to any of the control wires causes the catheter tip todeflect, giving control of orientation to the catheter tip, for examplegiving orientation control of the imaging angle of a tip mountedultrasound transducer. This technology has made more advanced procedurespossible using catheter-mounted instruments, benefiting patients withminimally invasive procedures, by entering a patient's bodypercutaneously or via natural orifices. Further descriptions thatreference guided catheters may also apply to guided sheaths.

SUMMARY

Apparatus and associated methods relate to a catheter manipulationhandle with user interface controls for steering a catheter in situwhile providing an augmented (e.g., motorized, powered and tunableprecision steering, and perforation safeguards) control and feedbackuser experience. In an illustrative example, the catheter manipulationhandle may provide motor assisted operation to automatically rotateand/or deflect a distal tip of the catheter to steer and guide thedistal tip to a target location in the patient's vasculature system. Theaugmented feedback may include, for example, haptic feedback via thehandle. Haptic, audible, and/or visual feedback via the handle mayindicate, for example, proximity or engagement of the distal tip withsensitive tissue. In some examples, the handle's augmented operation mayadvantageously amplify feedback signals to enhance the user's perceptionof the patient's safety with respect to the safe passage of the distaltip through the patient's vasculature.

Various embodiments may achieve one or more advantages. For example,some embodiments may employ an integrated active display to presentimages with a customizable user interface, which may advantageouslyprovide control of a catheter manipulation handle (CMH) with fingersliding motions, and providing a modern look.

In some embodiments, the CMH may determine the best control patternbased on preferences input by the user, and may advantageously allow auser to recall from CMH memory, common, particularly challenging orlengthy catheter move sequences from the CMH memory.

In some embodiments, the user may be in direct contact with the CMH,holding the CMH in the hand, such that the forces on the catheter fromthe catheter tip hitting a vessel wall, for example, may be feltdirectly by the user, which may advantageously provide a natural hapticfeedback. In some examples the various forces on the guide catheter areminute and may not be substantially felt by the user holding the CMH. Insome embodiments, haptic feedback may be artificially induced into thehandle, for instance with vibratory, audible, and/or visual feedback,which may advantageously provide a heightened sensor feedback experiencefor the user. In various implementations, a surgeon may prefer todirectly manipulate the patient-catheter interaction by receivingaugmented feedback signals supplied via the handle gripped by thesurgeon.

The details of various embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of an exemplary catheter manipulationhandle (CMH) in a user's hand illustrating operation.

FIG. 2 depicts a perspective view of an exemplary CMH, illustratingspecific functionality.

FIG. 3 depicts a perspective view of an exemplary CMH.

FIG. 4 depicts a schematic view of an exemplary CMH functional blockdiagram.

FIG. 5A depicts a perspective view of an exemplary CMH, illustrating alocking collar embodiment in an unlocked state.

FIG. 5B depicts a perspective view of an exemplary CMH, illustrating alocking collar embodiment in a locked state.

FIG. 6 depicts a perspective view of an exemplary CMH with a remotedisplay and audible feedback.

FIG. 7A depicts a perspective view of an exemplary CMH, illustrating auser interface with rotating concentric collar, carrying a circular“scroll wheel” sensor.

FIG. 7B depicts a perspective view of an exemplary CMH, illustrating areleasable mechanical and electrical interface.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

To aid understanding, this document is organized as follows. First, anexemplary catheter manipulation handle (CMH) is briefly introduced withreference to FIGS. 1-2 illustrating the CMH operation. Second, withreference to FIG. 3, discussion turns to exemplary embodiments thatillustrates CMH components, specifically an exemplary enclosure andcomponents attached to an outer enclosure. Third, with reference to FIG.4, a functional block diagram is presented. Finally, with reference toFIGS. 5-7, additional embodiments are presented to illustrate otherexemplary configurations.

FIG. 1 depicts a perspective view of an exemplary catheter manipulationhandle (CMH) in a user's hand illustrating operation. A guide catheterin a pre-insertion use case 100, is held by a doctor 105. The doctor 105holds a CMH 110, testing its operation. The CMH 110 contains an Xdeflection collar 115 and a Y deflection collar 120. The X deflectioncollar 115 and the Y deflection collar 120 may employ a detent positionin the center of their travel. The doctor may rotate the X deflectioncollar 115 and the Y deflection collar 120 independently to control acatheter 125 shape. The catheter 125 is made up of 2 sections: thecatheter proximal section 130 and the catheter distal end 135. Betweenthe catheter proximal section 130 and the catheter distal end 135, inthis embodiment, lies the distal bend 140. The doctor 105 may manipulatethe shape of the distal bend 140 by employment of the X deflectioncollar 115 and the Y deflection collar 120, advantageously direct thecatheter distal end 135. During a medical procedure, the catheter 125may be directed into a lumen on a patient and advanced into thepatient's vascular system. As the catheter 125 is advanced, the doctor105 may direct the catheter distal end 135 by rotating the X deflectioncollar 115 and the Y deflection collar 120 to steer the catheter intothe desired vascular path.

In detail A, the catheter distal end 135 has been cut away to show thecontrol wires. The X deflection collar 115 controls a first X deflectionsteering wire 145 and a second X deflection steering wire 150, such thatpulling on the first X deflection steering wire 145 and releasing thesecond X deflection steering wire 150, may deflect the catheter distalend 135 in one direction, for example to the left, and such that pullingon the second X deflection steering wire 150 and releasing the first Xdeflection steering wire 145, may deflect the catheter distal end 135 inthe opposite direction, for example to the right. (See FIG. 2).

The Y deflection collar 120 controls a first Y deflection steering wire155 and a second Y deflection steering wire 160, such that pulling onthe first Y deflection steering wire 155 and releasing the second Ydeflection steering wire 160, may deflect the catheter distal end 135 inone direction, for example upward, and such that pulling on the second Ydeflection steering wire 160 and releasing the first Y deflectionsteering wire 155, may deflect the catheter distal end 135 in theopposite direction, for example downward.

In some embodiments, the X and Y steering functionality may beaccomplished with fewer control wires, for example 1 wire for the Xdeflections and 1 wire for the Y deflections. In some embodiments, the Xand Y steering functionality may be accomplished with more controlwires.

FIG. 2 depicts a perspective view of an exemplary CMH, illustratingspecific functionality. The CMH is depicted in 3 specific catheterdistal end 135 deflection functions: deflection in the −x direction 200,no deflection 205, and deflection in the +x direction 210. Deflection inthe −x direction 200, is accomplished by moving the X deflection collar115 in the counter clockwise (CCW) direction as viewed from the catheterside of the CMH. The Y deflection collar 120 moves the catheter in the Ydirection, and is not used in this functional use case. No deflection205, is accomplished by leaving the X deflection collar 115, and the Ydeflection collar 120 in their detent positions. Deflection in the +xdirection 210, is accomplished by moving the X deflection collar 115 inthe clockwise (CW) direction as viewed from the catheter side of theCMH. The Y deflection collar 120 moves the catheter in the Y direction,and is not used in this functional use case.

FIG. 3 depicts a perspective view of an exemplary CMH. The exemplary CMH300 contains a collar 305. The collar 305 attaches to a capacitive touchwheel 310. The capacitive touch wheel 310 is wired to a control board315 via a first wire harness for example. The control board 315 is alsowired to the electromechanical actuators 320, for example motors, via asecond wire harness for example. The collar 305 may rotate and send itsrotational information to the control board 315 via a third wire harnessfor example. The electromechanical actuators 320, are contained within aproximal enclosure 325. The proximal enclosure 325, attaches to thedistal enclosure 330. In some embodiments, the collar 305, mayfacilitate the connection between the proximal enclosure 325 and thedistal enclosure 330. The distal enclosure 330 rotatably attaches to acatheter support cowling 335. The catheter support cowling 335 isgearably coupled to a transmission assembly 340. The transmissionassembly is gearably coupled to the electromechanical actuators 320. Theelectromechanical actuators 320 provide the mechanical actuation forcesto rotate the catheter support cowling 335. In the depicted figure, thecatheter support cowling 335 is releasably attached to a catheter 345.The CMH's releasable attachment of the catheter may advantageouslyprovide the ability to detach and dispose of the catheter 345, and mayprovide re-use of the CMH. When coupled to the catheter support cowling335, the catheter 345 is rotated by the catheter support cowling 335,which may advantageously provide additional catheter steeringflexibility, since the user may not only deflect the catheter tip in thedirection of catheter advancement, but may optionally rotate a pre-bentcatheter tip in that direction as well. The motor-assisted rotation ofthe support cowling 335, which rotates the catheter 345, substantiallyreduces the need for user-assisted manual handle rotation.

In some embodiments, the capacitive touch wheel 310 may be part of auser input and visual feedback feature that may take the form of a smalltouchscreen display. The touchscreen display may advantageously providean adaptable method of feeding back information, for example biologicalmeasurements to the user. In such embodiments, the small touchscreendisplay may advantageously change from showing catheter measurements,for example catheter tip temperature, to user input selections, such assteering arrow buttons, for example. Embodiments of a display devicecoupled to the CMH are described in further detail with reference toFIG. 6.

In some embodiments, the user feedback may take the form of visualindicators such as LEDs. The LEDs may advantageously provide the userwith visual feedback that may be noticed by the user's peripheralvision, for example a warning LED for catheter forces within the rangeof impending tissue perforation.

In some embodiments, the user input may take the form of conventionalbuttons. The conventional buttons may advantageously provide use behindsubstantially translucent sterile barriers. The user may benefit from atactile feel of a button under such barriers.

In some embodiments, the user may be in direct contact with the CMH,holding the CMH in their hand. The forces on the catheter from thecatheter tip hitting a vessel wall, for example, may be felt by theuser, which may advantageously provide a natural haptic feedback. Thishaptic feedback may be amplified or augmented by the CMH. In someembodiments, haptic feedback may be artificially induced into theproximal enclosure 325, for instance with a vibrator module. In someembodiments, the vibrational induction may be made by the existingelectromechanical actuators 320, which may advantageously repurpose theactuators to produce a vibration, for example in short bursts.

In some embodiments, the level of haptic experience may be predeterminedfor each user, which may advantageously provide suitable hapticsensations with amplification or gain customized and scaled to each userof the CMH. One or more user profiles may contain user preference ordefault amplification value configurations for various feedback signals.In some implementations, profile amplification configurations may bestored in a non-volatile memory space accessible by a processor in theCMH. During CMH operation, a surgeon, for example, may make inputs viathe user interface to select a desired feedback amplificationconfiguration suitable for a particular surgical procedure. During asurgical procedure, as an illustrative example, one or more hapticfeedback amplification configurations may be employed by retrievingcorresponding stored amplification settings from the non-volatilememory. The profile or configuration settings employed at any pointduring the surgical procedure may be, for example, dynamically selectedas a function of the type of surgical procedure, the determined chambervolume in which the distal tip is located, proximity to certainsensitive tissues, or a combination such factors.

In some embodiments, the catheter may provide the user feedback that abody cavity wall has been touched. In some examples the sensor providingthe touch sense may be a contact sensor, which may advantageouslyprovide high precision. In an illustrative example, during cardiacablations, the touch sensors may provide precise contact force anddirection information, which may advantageously provide data for cardiacmapping.

In some embodiments, the sensor may be a capacitive touch sensor, whichmay advantageously provide high sensitivity. The high sensitivityprovides medical teams with more useful and detailed data to aid in thediagnosis of medical conditions. In some examples the capacitive sensormay quantify a subjective sense of touch.

In some embodiments, the sensor may be a pressure sensor, which mayadvantageously provide substantial immunity to non-wall tissues andfluids.

In some embodiments, the sensor may be a force sensor, which mayadvantageously provide substantial immunity to non-wall tissues andfluids and may provide bending force information.

In some embodiments, the sensor may be ultrasonic, which mayadvantageously provide proximity information.

In some embodiments, the sensor may be part of the electromechanicalactuator, where the electrical current may be monitored to determine howmuch work is being done on the control wires, by a control systemoperating to maintain a commanded deflection angle of the catheter tip,allowing the CMH to warn the user to stop, for example.

In some embodiments, a force sensor may be provided on the controlwires, which may advantageously provide feedback to the user when thecurrent bend command may not be possible in the current catheter tipposition.

In some embodiments, the catheter tip may contain a combination of oneor more different types of sensors and/or different types of instrumentsthat cooperate to measure one or more biological functions, or toexecute one or more medical procedures. In these embodiments, thesignals to and from the sensors and instruments may route through theCMH.

In some embodiments, the electromechanical actuators 320 may provide thetension to the control wires as explained in FIG. 1 detail A. In someembodiments, the electromechanical actuators 320 may be a stepper motorwhich may advantageously provide substantially precise angular controlof the motor and therefore the tension to the control wires. In someembodiments, the electromechanical actuators 320 may be a servo, aconventional motor coupled to a sensor for position feedback, which mayadvantageously provide a simplified design for firmware. In someembodiments, electromechanical actuators 320 may be used to createrotational motion, which can be converted to a linear motion necessaryfor control wire actuation via a transmission mechanisms, for example, awinch mechanism, where multiple rotations of an axle to take in or letout wire, which may advantageously provide additional torque, a rockingcam wheel, where partial rotations to take in or let out wire, which mayadvantageously provide increased resolution of the catheter deflection,a reel mechanism with a stationary axle with a traveling shuttle to wrapthe wire, which may advantageously avoid control wire entanglement, a“feeder” wheel where tension is applied by friction on the control wiresrunning between two rolling wheels, which may advantageously provide aneasier maintainable device, or a cogged actuation where chain or atoothed belt interface to a gear, advantageously avoiding slippage.

In some embodiments, the electromechanical actuators 320 may employ forexample, solenoids or other electromagnetic forces to induce linearmotion, advantageously applying a direct push or pull.

In some embodiments, solenoid-type actuations may be imitated withhydraulic or pneumatic systems. In some embodiments, direct deformationof the catheter shaft may be achieved via targeted thermal expansion orcontraction or forces stemming from the piezoelectric effect uponapplication of voltage.

In some embodiments, additional methods for adjusting control wires maybe utilized without robotic (motorized) augmentation.

FIG. 4 depicts a schematic view of an exemplary CMH functional blockdiagram. The system 400 includes a handle module 405. The handle module405 electrically connects to a medical instrument, for example aninstrument that treats uncontrolled hypertension through renal nervedenervation via a catheter-based medical procedure, via a medicalinstrument port 410. The medical instrument port 410 passes the medicalinstrument signals to the catheter port 415. The catheter port 415connects to the detachable and disposable catheter with sensors 420.

The handle module 405 also includes the controller module 425. In someembodiments, the controller module 425 may represent the control boardas depicted in FIG. 3, item 315. The controller module 425 includes aprocessor 430 that acts as the main processing and control component forthe controller module 425.

The processor 430 connects to Non-Volatile Memory (NVM) 435 where theexecutable code 435A is programmed and contained. To facilitate theprocessor 430 functionality, connection to Random Access Memory (RAM)440 is provided. The processor 430, NVM 435, and RAM 440 build the basicdigital control platform. In some embodiments, the CMH may save stepsand catheter moves into the NVM 435, advantageously allowing a user toread from NVM 435 particularly difficult or lengthy catheter movesequences from CMH memory. In some embodiments, an entire sequence ofcatheter moves made for a specific patient may be saved to NVM 435, sothat a user may read from NVM 435 and replay those predetermined moves(deflections and/or rotations) for another catheter located in the sameor nearby lumen. In some embodiments, the CMH may be preprogrammed toexecute the exact number of catheter rotations required for a procedure,for example. In some embodiments, a map of rotational angles may besaved in the CMH memory, so that the user may employ the predeterminedsequence at a predetermined point in the medical procedure.

The processor 430 communicates to a display interface 445. The displayinterface 445 then drives the display 450. In some embodiments, thedisplay may be a capacitive touch wheel, that displays the functions ofthe capacitive touch wheel. In some embodiments, the display may belarge enough to display graphs of biological signals, which mayadvantageously provide additional patient statistics to the user. Insome embodiments, the display may provide catheter mapping to guide theuser in catheter steering procedure. In some embodiments, the displaymay provide instructions, which may advantageously provide ‘just intime’ training. In some embodiments, the CMH may provide the user, viathe user interface, a prompt when the user is to make the next cathetermove, which may advantageously provide catheter guide assistance to theuser.

The processor 430 also communicates to a user interface 455. The userinterface 455 then drives various indicators 460. The user interface 455is also responsible for reading the various user input 465, push buttonsfor example.

The processor 430 also communicates to wireless interface module 470.The wireless interface module 470 includes an antenna 470A. The wirelessinterface module 470 may provide wireless communication to a computer orother medical instrument, for example.

The processor 430 also communicates to an analog interface 475. Theanalog interface 475 is responsible for driving the haptic devices 480.The analog interface 475 is also responsible for receiving andconditioning the signals from the catheter port 415 which is connectedto the catheter and sensors 420. Finally, the analog interface 475contains the drive circuitry to drive the electromechanical actuators485.

The processor 430 also communicates to a communication port 490. Thecommunication port 490 is connected to the communication port interfaceconnector 495. The communication port interface connector 495,advantageously provides digital communication to the CMH, to enable userprogramming of the CMH from a computer for example. In some embodiments,the CMH may be programmed, by a computer connection, with an app, toperform certain surgeries, for example therapeutic or diagnostic.

The handle module 405 may contain the electronics and mechanicalcomponents that provide user interface controls to motor-assist and tomechanically augment a user's direct maneuvering of a guide catheter,and to provide haptic feedback to the user.

FIG. 5A depicts a perspective view of an exemplary CMH, illustrating alocking collar embodiment in an unlocked state. The unlocked collar CMHembodiment 500A, includes a handle proximal end 505. The handle proximalend 505 rotatably couples to the handle distal end 510. The handledistal end 510 rigidly couples to a catheter support cowling 515. Thecatheter support cowling 515 is releasably coupled to a catheter 520.The handle distal end 510 and the handle proximal end 505 are furtherslidably coupled to a locking collar 525A. The locking collar 525A isdepicted in the slid forward position, exemplifying an unlockedposition. In this position the user may freely rotate the locking collar525A. The locking collar 525A contains a user interface 530. In someembodiments, the user interface 530 may be a capacitive touch wheel,which may advantageously provide control of the CMH with finger slidingmotions, and provide a modern look. The handle distal end 510 rigidlycoupled to a catheter support cowling 515, may advantageously allow theuser to manually rotate the handle distal end 510 and the catheter 520around the longitudinal axis. In some embodiments, the handle distal end510 may be rotatably coupled to the catheter support cowling 515, andadvantageously allows the user to employ powered rotation of thecatheter 520 around the longitudinal axis.

FIG. 5B depicts a perspective view of an exemplary CMH, illustrating alocking collar embodiment in a locked state. The locked collar CMHembodiment 500B further depicts the collar 525B in a slid back position,exemplifying a locked position. In this position, the user may rotatethe locked collar embodiment to rotate the catheter 520.

In some embodiments, the locking collar 525A may function in the reversedirection. In such embodiments, the collar may slide toward the handleproximal end 505 to allow free rotation of the handle proximal end 505.The collar may then slide toward the handle distal end 510, to relockthe handle from rotation.

In some embodiments, the handle distal end 510 and the handle proximalend 505 may be rigidly coupled, such that the collar may enter and exitfree rotation by the lock and unlock action. In some embodiments, thehandle distal end 510 and the handle proximal end 505 may be unitary,which may advantageously reduce bill of materials parts count.

In some embodiments, the user interface 530 containing buttons,indicators and displays, for example, may be on the handle proximal end505, such that rotation of the handle proximal end 505 may allowreorientation of the controls toward the user.

In some embodiments, the locked position may provide control over anaxis of powered motion. In some examples a collar may employ anisometric sensor such that the user may apply rotational force to thecollar in either direction to control the catheter tip deflection. Insome examples, the collar may employ a toggle switch, such that the usermay rotate the collar in either direction to control the catheter tipdeflection. In some embodiments, the user interface 530 may control oneaxis of tip deflection, for example forward and backward, and the collarmay control a different axis of tip deflection, for example left andright.

In some embodiments, the CMH may allow the internal components torotate. In these embodiments, the electromechanical actuators may be ona bearing independent of the CMH enclosure. In these embodiments, thehandle may remain flat and substantially unmoving, while the user mayreposition the rotational position of the user interface, advantageouslyallowing the user to orient the user interface independent of the restof the CMH, and allowing the user to drive the CMH with one hand. Thelocking collar 525A may decouple from the rest of the CMH to reorientthe catheter tip.

In an illustrative implementation, a user may push the locking collar525B forward and advance the catheter 520 until the catheter tip hasreached a predetermined target destination in the patient. The user maythen snap the locking collar 525B back into place, and manipulate theCMH with one hand by using a thumb to drive the catheter tip in one axisand an index finger to drive the catheter tip in the other axis, forexample.

In some embodiments, the user interface 530 may use a capacitive touchsensor to receive user input. The capacitive touch sensor may be locatedin more than one position on the CMH, which may advantageously providethe user the ability to control the CMH with more than one finger orthumb. The user interface may be a single-axis strip, which mayadvantageously provide isolated control of each catheter axis. Thecapacitive touch sensors may be a ring, which may advantageously providean intuitive control motion, and may advantageously provide control witha single finger. The capacitive touch sensors may be a two-dimensionaltrackpad as employed on laptop computers, which may advantageouslyprovide unencumbered use under a sterile barrier. The capacitive touchsensors may be contoured which may advantageously provide optimizedergonomics. The capacitive touch sensors' inputs may provideposition-based or velocity-based response in the catheter tip. In someembodiments, the input force to the capacitive touch sensors mayadvantageously control tip response sensitivity or speed of the tip'sangular deflection and/or rotation.

In some embodiments, the user interface 530 may employ other types ofuser interface components, such as momentary switches, for example.Momentary switches may advantageously provide tactile feedback to theuser. Resistive switches may be employed on the user interfacecomponents to facilitate button actuation with a gloved hand.

In some embodiments, the CMH 500A may employ concentric collars aroundthe device, transducing rotation of the collar relative to the device.In some embodiments, the user interface 530 may employ a joystick, whichmay advantageously provide user-intuitive controlling motion. In someembodiments, the user interface 530 may employ a linear slider, whichmay advantageously provide decoupled axis control. In some embodiments,the user interface 530 may employ a wheel rotating on an axis, which mayadvantageously provide fast movement. In some embodiments, the userinterface 530 may employ a plane tilting on a central point, similar toa joystick, which may advantageously provide control through a sterilebarrier without encumbrance. In some embodiments, the user interface 530may employ a stationary “roller ball”, which may advantageously providetransducing inputs from rotation around two axes. In some embodiments,the user interface 530 may employ a graphical touch screen, providingdynamic interface, advantageously repurposing the user interfacefunctionality to provide only the inputs needed at the programmed time.In some embodiments, the user interface 530 may employ a remote wirelessdevice with any of the listed control inputs, advantageously speedingsetup and reducing the number of cables. In some embodiments, the userinterface 530 may employ direct translation, where the user directlymanipulates a physical model of the catheter tip to model the desiredcatheter tip movement, and the system responds by sensing the model'sposition based on flex sensors within the model or on machine visionprocessing performed on images from an external camera focused on themodel.

In some embodiments, the user interface 530 may combine multiple modesof input, for example a capacitive touch sensor on a concentric collaror linear slider. In some embodiments, the user interface 530 mayprovide control over a single axis at a time, or over multiple axessimultaneously.

FIG. 6 depicts a perspective view of an exemplary CMH with a remotedisplay and audible feedback. A CMH system 600, includes a CMH 605connected to a remote display 610. In some embodiments, the remotedisplay may include flexible twistable legs, such that the remotedisplay 610 may be mounted to other operating room equipment, forexample. The CMH 605 includes an audio transducer 615. In someembodiments, the user may benefit from an audible alert, in anenvironment that contains visual distractions, for example.

FIG. 7A depicts a perspective view of an exemplary CMH, illustrating auser interface with rotating concentric collar, carrying a circular“scroll wheel” sensor. A CMH 700A, is attached to an instrument, forexample an ultrasound generator, via an instrument cord 705. Theinstrument cord is releasably and electrically connected to aninstrument plug 710. The instrument plug 710 is included in a handle715. The handle 715 is rotatably attached to a rotating concentriccollar 720. The rotating concentric collar 720 is fixedly attached to acircular “scroll wheel” sensor 725. The rotating concentric collar 720is rotatably attached to a body 730. The body 730 is releasablyconnected to a replaceable catheter head 735. The replaceable catheterhead 735 includes an electrical catheter plug 740. The replaceablecatheter head 735 also includes 2 control wire plugs 745. Thereplaceable catheter head 735 is rigidly coupled to the catheter shaft750.

FIG. 7B depicts a perspective view of an exemplary CMH, illustrating areleasable mechanical and electrical interface. A CMH 700B, includes anelectromechanical actuator 755. The electromechanical actuator isfixedly attached to the pair of control wires 760. The control wires 760route to the body 730 where the control wires 760 attach to a pair ofcontrol wire jacks 765. The control wire jacks 765 removably attach tothe control wire plugs 745. The control wire plugs 745 are fixedlyattached to the replaceable catheter head 735. The replaceable catheterhead 735 includes the electrical catheter plug 740. The electricalcatheter plug 740, removably attaches to an electrical catheter jack770. The electrical catheter jack 770 electrically connects to a handlepass-through harness 775. The handle pass-through harness 775 connectsto the instrument plug 710. In some embodiments, a second electricalinterface is employed to route data to external equipment. A cathetercoupling consisting of 1) the mating pair of the electrical catheterplug 740, and the electrical catheter jack 770 and 2) the mating pair ofthe control wire plugs 745, and the control wire jacks 765, transmit theelectronic signal from the replaceable catheter head 735 to the CMH700B.

In some embodiments, the catheter coupling may allow the user toseparate the CMH 700B from replaceable catheter head 735. The cathetercoupling will provide a robust connection between the control wire plugs745, and the control wire jacks 765.

The catheter coupling will also provide a reliable electrical connectionbetween the electrical catheter plug 740, and to the electrical catheterjack 770, for example the electrical signals from an ultrasoundtransducer.

In some embodiments, the replaceable catheter head 735 may be latchedonto the body 730 with internal or external clips, which mayadvantageously provide quick attachment. In some embodiments, thereplaceable catheter head 735 may be screwed onto the body 730 withmulti-turn standard thread screws, which may advantageously provide asecure connection with a tool. In some embodiments, the replaceablecatheter head 735 may be latched onto the body 730 with or a ‘Luer Lock’type screw, which may advantageously provide a partial turn connectionthat is both secure and quick. Screw-type embodiments may involve thereplaceable catheter head 735 threading onto the body 730. In someembodiments, the application of discrete screws through clearance holesand into threaded receiving holes may be employed.

In some embodiments, the catheter coupling may include rigid ends on thecontrol wires 760, which may be captured within the replaceable catheterhead 735 by conformed (mating) receptacles. This may be achieved withthe rotation of the replaceable catheter head 735 relative of the body730, advantageously locking the replaceable catheter head 735 intoplace. In some embodiments, the control wires 760 may be captured byinserting barbed ends of the control wires 760 into replaceable plasticor hard rubber inserts on the body 730, or by implementing spring-actionbarbs such as employed, in small scale, on electrical crimp-connectorsinserted into plastic housings. In some embodiments, bare control wire760 ends may be guided directly through a friction-feed actuator.

In some embodiments, the catheter coupling may include magnets to directforce or to assist in guiding mating parts to their receptacle insidethe CMH 700B. In some embodiments, the catheter coupling may includescrews mating to the control wires 760. In some embodiments, thecatheter coupling may include screws perpendicular to the control wires760 to clamp the control wires 760 to the electromechanical actuator orto pass through a coupling hole. In some embodiments, the cathetercoupling may include a cylindrical, or helically wound braid to captureinserted parts, which may advantageously provide fast assembly. In someembodiments, the catheter coupling may include a cam lock as employed onpipe connections. In some embodiments, the catheter coupling may includea spring lock as employed on many in-line couplings, for example anexternal spring ring as employed on tractor hitches. In someembodiments, the catheter coupling may include an internally sprung ballbearing, as employed on bit driver handles. In some embodiments, thecatheter coupling may include a hook-shaped end passing through a holeto capture the mating piece.

In some embodiments, rotational motion may be transferred to thereplaceable catheter head 735, directly via gears, pulleys, or splinedshafts, wherein the replaceable catheter head 735 may convert rotationalmotion into the linear motion on the control wires 760.

In some embodiments, a tilting mechanism in the body 730 may couple to areceiving tilting mechanism within the replaceable catheter head 735. Insome embodiments, the mechanism may consist of a single multi-axisgimbal, providing a simplified operation. In some embodiments, multiplesingle-axis pivots may be employed, which may advantageously provideflexibility in many directions. In some embodiments, the replaceablecatheter head's 735 receiving tilting mechanism may be coupled directlyto the control wires 760.

In some embodiments, the replaceable catheter head 735 and the body 730may be permanently connected.

Although various embodiments have been described with reference to themechanical catheter coupling, other embodiments are possible. Forexample, some catheters may be rigidly coupled to a distal portion ofthe CMH, and the distal portion of the catheter may be driven to rotateby a motor drive in the CMH. In some examples, a motor drive (e.g.,stepper motor) may directly drive the distal portion, which in turnrotates the catheter about the longitudinal axis of the CMH. In someimplementations, a gear system may couple the motor to the distalportion, such that a higher speed motor operation may impart a highertorque, slower rotation to the catheter.

In some embodiments, the catheter coupling may transmit data and powerto and from a catheter tip transducer. In some embodiments, the catheterelectrical connection may be high speed and high bandwidth to allowtransmission of many channels of data and may provide power to operatean installed sensor. In some embodiments, the catheter coupling mayimplement high-density rectangular connectors consisting of two matingends: male pins and female receptacles. In some embodiments, thecatheter coupling may implement optoelectronic connections thattransduce electricity to and from packets of photons, including apossible transduction to optical signals within the transducer.

In some embodiments, the catheter coupling may implement spring pincontacts that interface by pressing onto receiving pads.

In some embodiments, the catheter coupling may implement printed circuitboard edge connectors.

In some embodiments, the electrical signals in the handle pass-throughharness 775 may pass the electrical catheter interface around the body730 through a wire bundle, for example, that may be connected witheither a standard rigid connection or a rotating interface to avoidwrapping the wire as the replaceable catheter head 735 and body 730 aremanipulated.

Although various embodiments have been described with reference to thefigures, other embodiments are possible. For example, some embodimentsmay allow manual over-ride control of the CMH, advantageously giving theuser a fallback operating mode while the CMH continues to provide hapticfeedback.

Various embodiments may employ user interface elements for generating arotation command signal in response to user input. A catheter rotatablycoupled to a CMH may rotate about a longitudinal axis in response torotation of a motor drive that is in turn rotated in response to arotational command signal. With reference to the figures describedabove, examples of user interface elements capable of generating arotation command signal may include, but are not necessarily limited to,items referred to as 115, 120, 310, 465, 530, 525A, 525B, 725, and 720.

In some embodiments, the user input signals may be conditioned accordingto user preference. Some embodiments may allow custom mapping of a‘transducer axis to catheter tip axis’ or tuning ‘actuator sensitivityto transducer input’. The system may also track session data to processwith learning tools and/or incorporating learning algorithms for usersto analyze their performance. This allows the use of the tracked datafor training purposes and optimization of user performance. Settings andtracked data may be accessible via internal or external softwareapplications.

In some embodiments, the CMH will include a “smart” interface capable ofcustomization that provides data tracking for training and otherpurposes. The “smart” interface may provide computer access to transferdata to and from the CMH. The “smart” interface may interface to anexternal computer running a software application, and may contain adashboard to manage the data collection and device configuration. The“smart” interface may allow the user to set the user interface controlsto a predetermined functionality and may allow the user to set thecatheter control sensitivity to a predetermined level.

Some embodiments may be disposable, advantageously eliminating the costof sterilization. Some embodiments may be non-disposable, advantageouslysaving the cost to hospitals and ultimately to the patient, ofpurchasing a new CMH for every procedure.

Some embodiments may determine the cavity space that the catheter iswithin. In these embodiments, the CMH may reduce the movement allowancethe user may execute, thereby re-calibrating the movement resolution. Insome examples the cavity sense may be accomplished using a proximitysensor. In some examples the cavity sense may be accomplished using aninfrared sensor. In some examples the cavity sense may be accomplishedusing an ultrasonic sensor. In some examples the cavity sense may beaccomplished using sound. In some examples the cavity sense may beaccomplished using optical means, for example camera imaging. In variousexamples, the cavity sense may employ ‘deep learning’ and patternrecognition in a wide variety of signals. By way of example and notlimitation, optical signals may be processed to recognize patterns.

In some examples the gain of the haptic feedback may be based on thedetected volume of the chamber and may allow the CMH to employ a‘predetermined sensitivity rating’ which may be automatically set, inresponse to the sensitivity of the area that the catheter is in or inresponse to the distance of the catheter advancement. In someembodiments, the automatic sensitivity setting may be a function of thecatheter tip force, the size of the chamber, or the chamber volume. Insome embodiments, the CMH may receive parameters that affect sensitivitysensing, such as chamber size, or chamber volume, from internal orexternal systems, including those that are provided to the user as partof the CMH or products from third-party suppliers.

In some embodiments, the electromechanical actuator may reach a torquelimit and provide a clicking sound and feel that may be haptic feedbackto the user.

In some embodiments, the rotatable collar may exist in more than onelocation on the CMH. In some embodiments, the user interface may existin more than one location on the CMH.

In an illustrative example, a surgeon may manipulate a guide catheterthrough a patient's femoral artery using the CMH. In various examples, asurgeon employs the user interface (UI) on the CMH to controlelectromechanical actuators within the CMH to pull on control wireswithin a guide catheter to deflect the catheter tip and thereby steerthe guide catheter to its destination, for example, to captureechocardiogram images in a patient's heart. The CMH may provideaugmented mechanical control with haptic feedback to the user whenperforming direct (e.g., not in a remote cockpit) guide catheter basedprocedures.

Some aspects of embodiments may be implemented as a computer system. Forexample, various implementations may include digital and/or analogcircuitry, computer hardware, firmware, software, or combinationsthereof. Apparatus elements can be implemented in a computer programproduct tangibly embodied in an information carrier, e.g., in amachine-readable storage device, for execution by a programmableprocessor; and methods can be performed by a programmable processorexecuting a program of instructions to perform functions of variousembodiments by operating on input data and generating an output. Someembodiments can be implemented advantageously in one or more computerprograms that are executable on a programmable system including at leastone programmable processor coupled to receive data and instructionsfrom, and to transmit data and instructions to, a data storage system,at least one input device, and/or at least one output device. A computerprogram is a set of instructions that can be used, directly orindirectly, in a computer to perform a certain activity or bring about acertain result. A computer program can be written in any form ofprogramming language, including compiled or interpreted languages, andit can be deployed in any form, including as a stand-alone program or asa module, component, subroutine, or other unit suitable for use in acomputing environment.

Suitable processors for the execution of a program of instructionsinclude, by way of example and not limitation, both general and specialpurpose microprocessors, which may include a single processor or one ofmultiple processors of any kind of computer. Generally, a processor willreceive instructions and data from a read-only memory or a random-accessmemory or both. The essential elements of a computer are a processor forexecuting instructions and one or more memories for storing instructionsand data. Storage devices suitable for tangibly embodying computerprogram instructions and data include all forms of non-volatile memory,including, by way of example, semiconductor memory devices, such asEPROM, EEPROM, and flash memory devices; magnetic disks, such asinternal hard disks and removable disks; magneto-optical disks; and,CD-ROM and DVD-ROM disks. The processor and the memory can besupplemented by, or incorporated in, ASICs (application-specificintegrated circuits). In some embodiments, the processor and the membercan be supplemented by, or incorporated in hardware programmabledevices, such as FPGAs, for example.

In some implementations, each system may be programmed with the same orsimilar information and/or initialized with substantially identicalinformation stored in volatile and/or non-volatile memory. For example,one data interface may be configured to perform auto configuration, autodownload, and/or auto update functions when coupled to an appropriatehost device, such as a desktop computer or a server.

In some implementations, one or more user-interface features may becustom configured to perform specific functions. An exemplary embodimentmay be implemented in a computer system that includes a graphical userinterface and/or an Internet browser. To provide for interaction with auser, some implementations may be implemented on a computer having adisplay device, such as an LCD (liquid crystal display) monitor fordisplaying information to the user, a keyboard, and a pointing device,such as a mouse or a trackball by which the user can provide input tothe computer.

In various implementations, the system may communicate using suitablecommunication methods, equipment, and techniques. For example, thesystem may communicate with compatible devices (e.g., devices capable oftransferring data to and/or from the system) using point-to-pointcommunication in which a message is transported directly from the sourceto the first receiver over a dedicated physical link (e.g., fiber opticlink, point-to-point wiring, daisy-chain). The components of the systemmay exchange information by any form or medium of analog or digital datacommunication, including packet-based messages on a communicationnetwork. Examples of communication networks include, e.g., a LAN (localarea network), a WAN (wide area network), wireless and/or opticalnetworks, and the computers and networks forming the Internet. Otherimplementations may transport messages by broadcasting to all orsubstantially all devices that are coupled together by a communicationnetwork, for example, by using Omni-directional radio frequency (RF)signals. Still other implementations may transport messagescharacterized by high directivity, such as RF signals transmitted usingdirectional (i.e., narrow beam) antennas or infrared signals that mayoptionally be used with focusing optics. Still other implementations arepossible using appropriate interfaces and protocols such as, by way ofexample and not intended to be limiting, USB 2.0, Fire wire, ATA/IDE,RS-232, RS-422, RS-485, 802.11 a/b/g, Wi-Fi, WiFi-Direct, Li-Fi,BlueTooth, Ethernet, IrDA, FDDI (fiber distributed data interface),token-ring networks, or multiplexing techniques based on frequency,time, or code division. Some implementations may optionally incorporatefeatures such as error checking and correction (ECC) for data integrity,or security measures, such as encryption (e.g., WEP) and passwordprotection.

In some embodiments, the CMH may be a handheld robotically augmentedcatheter steering handle, the augmentation may advantageously providevision, precision and feedback to the user.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made. For example,advantageous results may be achieved if the steps of the disclosedtechniques were performed in a different sequence, or if components ofthe disclosed systems were combined in a different manner, or if thecomponents were supplemented with other components. Accordingly, otherimplementations are contemplated within the scope of the followingclaims.

What is claimed is:
 1. A hand-held catheter apparatus comprising: ahandle body extending from a proximal end to a distal end along alongitudinal axis; a user input interface on an outer surface of thehandle body, wherein the user input interface generates a rotationcommand signal in response to user input at the user input interface; arotational actuator module positioned in the handle body and having arotatable output, wherein the rotational actuator module controls anangular rotation of the rotatable output in response to the rotationalcommand signal; a catheter interface rigidly coupled to a catheterstructure extending distally therefrom, the catheter interface rotatablycoupled to a distal end of the handle body and coupled to rotate thecatheter interface about the longitudinal axis in response to rotationof the rotatable output; a first deflection actuator configured toimpart a first deflection angle command in a first plane to a steerabletip at a distal end of the catheter; a feedback interface on the handlebody configured to couple to the catheter interface to receive feedbacksignals from feedback elements in the catheter; and, a processordisposed in the handle body and operably coupled to receive the feedbacksignals and to generate in response thereto a predetermined hapticfeedback to the user while the user is holding the handle body.
 2. Theapparatus of claim 1, wherein the handle body further comprises a hollowregion that contains the rotational actuator module.
 3. The apparatus ofclaim 1, further comprising a grip portion formed at the proximal endfor being gripped by a user performing a catheter procedure in the bodyof a patient.
 4. The apparatus of claim 1, further comprising a gearmodule to couple the rotatable output to the catheter interface.
 5. Theapparatus of claim 1, wherein the processor further generates the firstdeflection angle command in response to a first user input deflectioncommand signal received at the user interface.
 6. The apparatus of claim1, wherein the processor is configured to generate the predeterminedhaptic feedback at a predetermined amplification.
 7. The apparatus ofclaim 6, wherein the predetermined amplification is based on apredetermined sensitivity of the patient tissue proximate to the distaltip of the catheter.
 8. The apparatus of claim 1, wherein the processoris further configured to modulate the predetermined haptic feedback inresponse to the received feedback signals indicative of a volume ofspace proximate to the distal tip of the catheter.
 9. The apparatus ofclaim 8, wherein the processor is further configured to perform patternrecognition on the received feedback signals to determine the volume ofspace proximate to the distal tip of the catheter.
 10. A hand-heldcatheter apparatus comprising: a handle body extending from a proximalend to a distal end along a longitudinal axis; a user input interface onan outer surface of the handle body, wherein the user input interfacegenerates a rotation command signal in response to user input at theuser input interface; a rotational actuator module positioned in thehandle body and having a rotatable output, wherein the rotationalactuator module controls an angular rotation of the rotatable output inresponse to the rotational command signal; a catheter interface rigidlycoupled to a catheter structure extending distally therefrom, thecatheter interface rotatably coupled to a distal end of the handle bodyand coupled to rotate the catheter interface about the longitudinal axisin response to rotation of the rotatable output; a feedback interface onthe handle body configured to couple to the catheter interface toreceive feedback signals from feedback elements in the catheter; and, aprocessor disposed in the handle body and operably coupled to receivethe feedback signals and to generate in response thereto a predeterminedhaptic feedback to the user while the user is holding the handle body.11. The apparatus of claim 10, wherein the handle body further comprisesa hollow region that contains the rotational actuator module.
 12. Theapparatus of claim 10, further comprising a grip portion formed at theproximal end for being gripped by a user performing a catheter procedurein the body of a patient.
 13. The apparatus of claim 10, furthercomprising a gear module to couple the rotatable output to the catheterinterface.
 14. The apparatus of claim 10, wherein the processor isconfigured to generate the predetermined haptic feedback at apredetermined amplification.
 15. The apparatus of claim 14, wherein thepredetermined amplification is based on a predetermined sensitivity ofthe patient tissue proximate to the distal tip of the catheter.
 16. Theapparatus of claim 10, wherein the processor is further configured tomodulate the predetermined haptic feedback in response to the receivedfeedback signals indicative of a volume of space proximate to the distaltip of the catheter.
 17. The apparatus of claim 16, wherein theprocessor is further configured to perform pattern recognition on thereceived feedback signals to determine the volume of space proximate tothe distal tip of the catheter.
 18. A hand-held catheter apparatuscomprising: a handle body extending from a proximal end to a distal endalong a longitudinal axis; means for generating a rotation commandsignal in response to user input; a rotational actuator modulepositioned in the handle body and having a rotatable output, wherein therotational actuator module controls an angular rotation of the rotatableoutput in response to the rotational command signal; a catheterinterface rigidly coupled to a catheter structure extending distallytherefrom, the catheter interface rotatably coupled to a distal end ofthe handle body and coupled to rotate the catheter interface about thelongitudinal axis in response to rotation of the rotatable output; afeedback interface on the handle body configured to couple to thecatheter interface to receive feedback signals from feedback elements inthe catheter; and, a processor disposed in the handle body and operablycoupled to receive the feedback signals and to generate in responsethereto a predetermined haptic feedback to the user while the user isholding the handle body.
 19. The apparatus of claim 18, wherein theprocessor is configured to generate the predetermined haptic feedback ata predetermined amplification.
 20. The apparatus of claim 19, whereinthe predetermined amplification is based on a predetermined sensitivityof the patient tissue proximate to the distal tip of the catheter.